We are partnering with a privately held medical device manufacturer looking to add a top performer to their Quality team. This person will need experience in an ISO 13485 environment and the ability to come in and hit the ground running. Great time to get your foot in the door with a growing, mid-sized manufacturer!
- Maintain the complaint system, including documenting, reviewing, investigating and closing complaints - Review, investigate and document CAPA's - Support inspections and audits as needed - Maintain the calibration system - Provide support to Manufacturing, Engineering and Regulatory as needed - Ability to confidently interact with customers - Assist in compiling design history files
Desired Skills and Experience
- B.S. Engineering or related field - 3+ years of engineering experience within a medical device manufacturing environment - Experience with internal/external audits - Strong attention to detail and documentation skill - Ability to communicate with cross functional teams, and customers
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